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Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder (Aug1)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00045903
First received: September 13, 2002
Last updated: April 22, 2014
Last verified: October 2012
  Purpose

This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy)
Behavioral: Stress Management Therapy (Cognitive Behavior Therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: CBT Augmentation for SRI Pharmacotherapy in OCD

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Obsessive-compulsive symptoms measured at Month 2 [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General functioning measured at Month 2 [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: August 2000
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exposure and Ritual Prevention
Exposure and Ritual Prevention Therapy
Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy)
Active Comparator: Stress Management
Stress Management Therapy
Behavioral: Stress Management Therapy (Cognitive Behavior Therapy)

Detailed Description:

Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00389493

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obsessive-Compulsive Disorder (OCD) diagnosis
  • Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD

Exclusion Criteria:

  • Medical or psychiatric conditions that would make participation in the study hazardous
  • Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045903

Locations
United States, New York
New York State Psychiactic Institute, Anxiety Disorders Clinic
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Michael Liebowitz, MD New York State Psychiatric Institute
Principal Investigator: Edna Foa, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00045903     History of Changes
Other Study ID Numbers: IRB #4734R, R01MH045436-01, DSIR AT-CT
Study First Received: September 13, 2002
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders

ClinicalTrials.gov processed this record on November 24, 2014